FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

This is a reprint of an FDA Alert

For Immediate Release
November 27, 2018

The U.S. Food and Drug Administration is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s).

These products continue to be sold at gas stations and convenience stores, as well as on websites such as eBay and Amazon. More recently, these unapproved products have been discovered in international mail shipments to the U.S. These products are often sold in single-serving package sizes. Rhino products include names such as Platinum Rhino 25000, Krazzy Rhino 25000 and Gold Rhino 25000.

The FDA has received reports of people experiencing chest pain, severe headaches and prolonged erections after taking a Rhino product that led to surgical intervention and hospitalization due to extreme drops in blood pressure.

“Over the past few years, the FDA has been combatting the retail sale of male enhancement drug products that are frequently misrepresented as dietary supplements and that contain hidden and potentially harmful active drug ingredients. Distributing unapproved drugs, disguised as supplements, places the U.S. public health at risk,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We remain vigilant in our efforts to protect the American public from the sale of these potentially dangerous products.”

Since 2015, the FDA’s Office of Criminal Investigations has been investigating a South Korean national living in the Los Angeles area for smuggling raw materials, producing Rhino capsules and distributing the misbranded drug products throughout the U.S. The case led to an indictment, which is being prosecuted by the U.S. Department of Justice. The FDA continues to pursue regulatory and criminal actions against those who violate federal law.

The FDA has posted warnings that these Rhino products contain undeclared ingredients that are the same as or structurally similar to active ingredients found in FDA-approved prescription drugs used to treat erectile dysfunction. For example, the FDA has identified various Rhino products containing sildenafil and/or tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively. These undeclared ingredients are phosphodiesterase type-5 (PDE-5) inhibitors, which can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Hidden active drug ingredients continue to be identified in products that are misrepresented as dietary supplements and promoted for sexual enhancement, weight loss, bodybuilding and/or pain relief. Over the past decade, the FDA has posted on its website hundreds of public warnings and recall announcements related to these types of fraudulent products. The FDA’s tainted products database can help consumers identify some of these potentially harmful products. However, FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Even if a product is not included in the list, consumers should be cautious about using certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding and/or pain relief. Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market. However, it is not possible for the agency to test and identify all tainted products.

If you are using or considering using any product marketed as a dietary supplement, the FDA suggests that you:

Talk to your health care practitioner first, as ingredients in dietary supplements may interact with medications you are taking or with other dietary supplements.

Use common sense. Claims that sound too good to be true probably are; search for information using noncommercial sites rather than depending on information provided by sellers.

Report any reactions, adverse events, or other concerns about a product to the FDA and to the product’s manufacturer so we can take action to protect the public from any unsafe products.

Consumers who have experienced an adverse health effect that may be related to a dietary supplement or who find defects in the quality or safety of a dietary supplement they’re taking are encouraged to report it through the FDA’s MedWatch Safety Information program.

Consumers can find the latest alerts, health information and FDA actions on tainted products by signing up for the FDA’s RSS feed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.